A Randomized, Clinical Trial of Oral Midazolam Versus Oral Ketamine for Sedation During Laceration Repair.

Lacerations Clinical Trial

Official title: A Randomized, Clinical Trial of Oral Midazolam Versus Oral Ketamine for Sedation During Laceration Repair.

Status Recruiting

Clinical Trial Summary

Sedation is often needed for young children undergoing minor procedures in the emergency department (ED). Oral midazolam is one of the most commonly used regimens for children undergoing laceration repair but its sedative efficacy was shown to be suboptimal. In only one randomized controlled study oral ketamine has been used successfully for procedural sedation for laceration repair. A recent study showed that the combination of oral midazolam and oral ketamine provided deeper sedation compared with oral midazolam alone. However children treated wuth the combination of midazolam and ketamine required longer recovery

Hypothesis:

Oral ketamine can provide superior sedation to oral midazolam in children requiring sedation for laceration repair.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lacerations

• NCT number: NCT01925898
• Study type: Interventional
• Source: Assaf-Harofeh Medical Center
• Contact: Eran Kozer, MD
• Phone: 972-8-9779916
• Email: erank@assaf.health.gov.il
• Status: Recruiting
• Phase: Phase 4
• Start date: August 2013
• Completion date: July 2014